Health Condition 1: N944- Primary dysmenorrhea
Conditions
Interventions
Intervention1: Individualized homoeopathic medicines: Known homoeopathic pharmacopoeial preparations in different potencies.
Control Intervention1: Identical placebo: unmedicated sugar pills
Sponsors
Central Council for Research in Homoeopathy
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients conformed to the diagnostic criterion of Primary Dysmenorrhoea according to the Primary Dysmenorrhea Consensus Guidelines and if they had experienced primary dysmenorrhoea for two or more months. 2.Age between 13 to 19 years. 3.Menstrual cycle(21 to 35) days. 4.Pain on numeric rating scale (NRS) >4. 5.Signed informed consent of the parent and assent of the children.
Exclusion criteria
Exclusion criteria: 1.Secondary dysmenorrhea caused by endometriosis, uterine myoma, endometrial polyps, pelvic inflammatory disease, or other gynecological problems confirmed by a gynecological, abdominal ultrasound examination. 2.Females with irregular/infrequent menstrual cycles (outside of the typical range 21 to 35 day’s cycle) 3.Patients with haemoglobin less than 7gm/dl. 4.Patients complicated with severe diseases (e.g. cerebral, liver, kidney, systemic diseases, mental disorders) 5.Received other alternative therapies such as massage, acupressure, herbal therapy in the previous one month. 6.Those who have been treated with hormone drugs over the last 3 months. 7.poor treatment compliance (e.g. unstable working and living situation, difficult follow-up).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of pain days in Homoeopathic group as compared to placebo group over 6 months.Timepoint: At baseline and then every month over 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the change in intensity of pain of dysmenorrhea on numeric rating scale over 6 months.Timepoint: At baseline and then every month over 6 months;To evaluate the reduction in consumption of analgesics over 6 months.Timepoint: At baseline and then every month over 6 months;To evaluate the changes in working ability, location, intensity, days of pain, dysmenorrhea (WaLIDD) score over 6 months.Timepoint: At baseline and then every month over 6 months;To evaluate the changes in mean number of reporting absenteeism days from school/work over 6 months.Timepoint: At baseline and then every month over 6 months;To evaluate the changes in scores of Menstrual distress questionnaire (MDQ) at 3rd and 6th month.Timepoint: At baseline, 3rd and 6th month. | — |
Countries
India
Contacts
Public ContactDr Varanasi Roja
Dr D P Rastogi Central Research Institute for Homoeopathy
Outcome results
None listed